The present invention relates to a tracheostomy tube particularly a tracheostomy tube having an inflation tube for inflating a cuff for forming a seal with the tracheal wall of a patient.
Tracheostomy tubes have been used for some time to provide a bypass supply of air or mixture of gases to a patient having an obstruction in the larynx or the pharynx area of the throat. The distal end of an outer cannula is inserted into the trachea through an incision in the patient's neck below the obstructed area. The proximal end of the outer cannula remains outside the trachea in communication with ambient air to permit passage of such air into the trachea. U.S. Pat. No. 3,693,624, also assigned to the assignee of the present invention, discloses a tracheostomy tube having an inner cannula which serves as an inner liner of the outer cannula and can be removed, cleaned, and then replaced. The proximal end of the tube can also be attached to a respiratory device to assist the patient's breathing. The distal end also includes an inflatable cuff to seal the distal end of the outer cannula within the tracheal wall to further assist the patient's breathing on the respiratory device, as described in U.S. Pat. No. 3,659,612 assigned to the assignee of the present invention and incorporated herein by reference.
The cuff is inflated and deflated by a small, flexible inflation tube and has a small valve at the proximal end of the inflation tube. The inflation tube has one end sealed within the cuff and is further fixedly bonded within a recess which extends from the cuff to the proximal end along the lower wall portion of the outer cannula. The remainder of the inflation tube extends unsecured and generally perpendicularly away from the proximal end of the outer cannula.
The unsecured portion of the inflation tube is subjected to various forces during inflation, deflation and normal handling while in use. In some (about 1 percent) of the tracheostomy tubes of the prior art, after only a few weeks of use, the inflation tube breaks at the point where it was fixedly bonded at the proximal end of the outer cannula. When the inflation tube breaks, the cuff deflates and cannot be resealed within the tracheal wall. The tracheostomy tube must then be replaced for patients requiring ventilation, at considerable inconvenience and expense.